1. Field of the Invention
The invention relates to a method for interconnection of and fluid communication between two tubular organs via an opening in an end of an end portion of a first organ and an aperture in a side wall of a second organ.
The invention also relates to a device for implementation of the method.
2. Description of the Related Art
Among those skilled in the art an increasing interest in minimally invasive surgery and a general desire to reduce the dependence on individual skills for carrying out operations has led to a need for a new method and a new device for anastomosing (connecting) tubular organs such as blood vessels. In contrast to ordinary operations, in the case of minimally invasive surgery, the access to the organs concerned or the target organs is extremely limited, which makes the use of standard anastomosis techniques based on manual suturing of the organs difficult and in some cases impossible. This difficulty is particularly relevant in the surgical field associated with coronary artery bypass, since an anatomical and physiological idiosyncrasy (hypersensitivity) of the heart results in very little tolerance of mistakes in this area when performing the procedure. Furthermore, the brief period required for anastomosis of blood vessels by suturing in neurovascular and aortic operations has largely prevented the use of less invasive surgical procedures.
Over the years many devices for anastomosis of blood vessels and similar tubular organs and methods for use of such devices have been disclosed in the patent literature.    U.S. Pat. No. 2,127,903 (Bowen)    U.S. Pat. No. 3,155,095 (Brown)    U.S. Pat. No. 3,620,218 (Schmitt et al.)    U.S. Pat. No. 3,683,926 (Suzuki)    U.S. Pat. No. 4,214,586 (Mericle)    U.S. Pat. No. 4,366,819 (Castor)    U.S. Pat. No. 4,368,736 (Castor)    U.S. Pat. No. 4,470,415 (Wozniak)    U.S. Pat. No. 4,675,008 (Tretbar)    U.S. Pat. No. 4,512,761 (Raible)    WO 97/27898 (Evard et al.)    U.S. Pat. No. 4,552,148 (Hardy, Jr. et al.)    U.S. Pat. No. 4,753,236 (Healy)    U.S. Pat. No. 4,769,029 (Patel)    U.S. Pat. No. 4,851,001 (Taheri)    U.S. Pat. No. 4,816,028 (Kapadia et al.)    U.S. Pat. No. 4,957,499 (Lipatov et al.)    U.S. Pat. No. 5,156,691 (Ehrenfeld)    U.S. Pat. No. 5,123,908 (Chen)    U.S. Pat. No. 5,192,289 (Jessen)    U.S. Pat. No. 5,250,058 (Miller)    U.S. Pat. No. 5,222,963 (Brinkerhoff et al.)    U.S. Pat. No. 5,330,490 (Wilk et al.)    U.S. Pat. No. 5,364,389 (Anderson)    U.S. Pat. No. 5,399,352 (Hanson)    U.S. Pat. No. 5,425,738 (Gustafson et al.)    U.S. Pat. No. 5,425,739 (Jessen)    U.S. Pat. No. 5,443,497 (Venbrux)    U.S. Pat. No. 5,445,644 (Pietrafitta et al.)    U.S. Pat. No. 5,456,712 (Maginot)    WO 00/72764 (Stevens et al.)    U.S. Pat. No. 5,456,714 (Owen)    U.S. Pat. No. 5,503,635 (Sauer et al.)    U.S. Pat. No. 5,509,902 (Raulerson)    U.S. Pat. No. 6,179,849 (Yencho et al.)
None of the objects of these publications are employed by skilled people in the field of vascular surgery. New developments in the field, however, offer again indications that anastomosis by means of suturing may soon become obsolete. Even though the new methods and devices represent improvements in relation to those previously used, however, they are all encumbered with drawbacks particularly in connection with minimally invasive surgery.
The device GraftConnector™ (WO 01/13820 (Solem)) comprises a Stents shape for securing the inlet branch to the outlet branch internally in a cavity when performing an anastomosis. Experience with percutaneous Stents shapes, however, raises doubts concerning foreign objects which are left in a blood vessel.
Results reported to date concerning automated suturing with V-Drive™ (Bolduc (WO 99/62415)) have not been promising. The execution of each anastomosis takes an average of 15 minutes and the technique is more difficult than in normal suturing (Martens S. et al. CTT Cardiothoracic Techniques VIII, 2002).
The execution of anastomosis with AutoSutur OneShot™ (U.S. Pat. No. 6,024,748 (Manzo)), while reducing the operating time, also increases the risk of vascular damage, thus cancelling out the benefit (Heijmen R. H. et al., J. Thoracic Cardiovascular Surgery 1999, 117:117-25).
Peripheral hoops (Symmetry™, Corlink™), which are described by Peterson et al. (U.S. Pat. No. 6,152,937), Swanson et al. (U.S. Pat. No. 5,113,621) and Loshakove et al. (LWO/56226, WO 00/56228, WO 01/70119) are not encumbered with the above-mentioned disadvantages.
With these devices, however, barbs are used to attach them to the organs undergoing anastomosis, resulting in a need for the use of complicated, manual operations. In addition to complicating the anastomosis procedure, this limitation actually makes the devices unsuitable for use in remotely controlled (telesurgical) procedures, which will probably replace standard treatment in the coming decades. In addition, the devices have to be made of expensive superelastic alloys, thus preventing widespread use for financial reasons. Thus a need still exists for a simple and inexpensive device which has a long working life, and which permits a rapid and reliable anastomosis of two hollow organs without the use of suturing.